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FDAFDA · Food and drugs·Recall number Z-1581-2014

DISP 9730950 STRL SPHERE, 1 PK INSERT

Published November 26, 2014 · Recall initiated: April 24, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Medtronic Navigation, Inc.
Distributor
Nationwide Distribution
Lot
Lot No.: B135276281
Risk classification
Class II
Area (FDA)
device
Country
United States

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